Surgical drape plume evacuator

ABSTRACT

A surgical drape plume evacuator includes a filter enclosure. An operating aperture disposed in the filter enclosure defines an area within the filter enclosure. A pressure source for creating at least one of a negative and positive air pressure in the filter enclosure. A fluid opening in the operating aperture connects the interior of the operating aperture to the interior of the filter enclosure.

BACKGROUND OF THE INVENTION

The present invention relates to improvements in smoke removal insurgical areas, and more particularly to a smoke evacuating device forsurgical use, which is simple in structure, can be made of low costmaterials, and as a result is disposable.

Handheld electrosurgical instruments are well known in the art. Theseinstruments take the form as electrocautery or laser surgical deviceswhich are used in a multitude of different types of surgeries for thebloodless cutting of tissue with the simultaneous cauterizing of vesselswhich stop the bleeding. During surgical use, localized heat generatedby the electrical discharge or heat source causes noxious smoke to beproduced. Because of the high temperatures, the smoke cloud risesrapidly from the point of the incision by the cautery instrument.

Surgical drapes are well known in the art. They are used in minor andmajor surgeries to keep the operating field sterile and free fromcontamination. Typically, the surgical drape is fenestrated and has anaperture to enable the surgeon to access the surgical site withoutcontaminating the surgical field. The surgical drape, as it is currentlyused, has no other function other than to serve as barrier that offersprotection from contamination of the surgical field.

Even in the presence of current surgical drapes, the smoke producedduring electrosurgery, often has a strong, persistent and unpleasantodor. This noxious odor can cause a vaso-vagal response in consciouspatients undergoing minor surgery. Additionally, the smoke comprisesorganic gases, water vapor, visible and sub-visible solid particles,infectious microbacterial organisms, infectious viruses and virusparticles, and carcinogenic substances, each of which is potentiallyharmful to the patient and the operating room staff. As a result, it isconsidered good practice to remove the smoke from the surgical field andfilter it to minimize any potential harm. Lastly, when produced insufficient volume, the smoke obscures the surgeon's view of theoperative field.

There are prior art systems, making use of a vacuum to remove the smoke,such as that known from U.S. Pat. No. 5,460,602, which places a vacuumnozzle adjacent the cutting tip of the electrocautery device. Thisdevice has been satisfactory, however, it suffers from the disadvantagethat it requires an entire distinct system which is siamese connected tothe existing surgical instrument. This results in a more complexstructure, which changes the feel of the surgical instrument, and byadding size to the surgical instrument also may obscure the surgeon'sview of the operative field.

Because of this, it is still common practice to have an assistant hold aseparate evacuating device near the surgical area. However, this suffersfrom the disadvantage of requiring two people, who often when not infull coordination, interfere with each other. And, since an additionalperson is holding the evacuating device in the surgical field, theprocedure may require an additional third person to provide surgicalassisting such as cutting sutures, retracting tissue and holdinginstruments in the surgical field. However, too many people can becomecumbersome for the surgeon particularly in limited surgical areas. Thereis also the opportunity cost of requiring additional people for a singleoperation. Additionally, the use of vacuum devices generating adequatesuction is a deterrent to the surgeon as a result of the noise createdby the vacuum frequently over 80 db and affecting communication withstaff and patient. Lastly, vacuum devices also suffer from powerinefficiencies.

It is also known from the art from U.S. Pat. No. 4,921,492 to use aplume evacuator and effector. The plume evacuator includes an evacuationhose adapted for detachable connection to a vacuum generator. There is afilter along the hose. The vacuum head is made of a pliable material todefine an evacuation plenum. A porous plenum supporting material iscarried within the plenum to provide rigidity to the plenum and toprevent the plenum from collapsing when subjected to the vacuum. Thisprior art device has also been satisfactory, but it still requires theuse of a hose integrally formed with a plenum coupled to expensive noisyand inefficient vacuum equipment. The plenum is integral with a flexiblehose which is coupled to a collector head within the plenum formed of anon-porous, pliable synthetic resin. While the pieces are formed ofresin, and reusable as the resin may lend itself to a sterilizationprocess, resin pieces are still expensive, and may not be amenable tocomplete sterilization given the length of the hose necessary to reach avacuum.

Currently, all prior art systems require the addition of another pieceof equipment/device to the surgical field. That device is the sterilesurgical drape. All prior art must avoid disturbing the sterile surgicaldrape and the sterile surgical field or any sterile surgical instrument.The necessity of prior art to avoid contaminating the sterile surgicalfield and still obviating the need for a surgical drape is oftendisruptive and burdensome to the surgeon and may be disruptive to thesurgery. Prior art necessitates a change by the surgeon to either hisinstruments, surgical staffs and surgeon's approach to the surgicalfield, or communication with the patient such that most surgeons chooseto not use prior art at great health risk to the surgeon and thepatient. Prior art solutions are not readily adopted because it requiresthese changes and adjustments by the surgeon and the staff.

Accordingly, a plume evacuation system which overcomes the shortcomingsof the prior art is desired.

BRIEF SUMMARY OF THE INVENTION

A surgical drape plume evacuator includes a filter enclosure, surgicaldrape and plume evacuator. An operating aperture is disposed in thefilter enclosure and separates an area defined by the operating aperturefrom the remainder of the filtered enclosure by creating a barrierbetween the filtered enclosure and the interior of the operatingaperture. A pressure source creates at least one of a negative andpositive pressure within the filtered enclosure and extending to theoperating aperture. The operating aperture provides access to a surgicalsite and fluidly connects the interior of the operating aperture to theinterior of the filtered enclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the present invention will beapparent from the written description and the drawing in which:

FIG. 1 is a schematic plan view of an evacuator constructed inaccordance with the invention.

FIG. 2 is a perspective view of the operating aperture portion of theevacuator constructed in accordance with the invention;

FIG. 3 is a perspective view of an evacuator constructed in accordancewith a second embodiment of the invention;

FIG. 4 is a front perspective view of a conduit used in the evacuator,constructed in accordance with the invention;

FIG. 5 is a side perspective view of the conduit used in the evacuatorconstructed in accordance with the invention;

FIG. 6 is a perspective view of an evacuator constructed in accordancewith yet another embodiment of the invention;

FIG. 7 is a side elevational view of a conduit constructed in accordancewith yet another embodiment of the invention;

FIG. 8 is a top plan view of the conduit constructed in accordance withthe yet another aspect of the invention; and

FIG. 9 is a perspective view of the conduit constructed in accordancewith the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Reference is first made to FIG. 1, in which a surgical drape plumeevacuator system, generally indicated as 10, includes a filter enclosure12 formed of two spaced sheets of porous filter material joined at theedges. Each sheet of the filter material is joined at an edge 14 ofenclosure 12, so that if inflated, enclosure 12 takes shape like apillow. In a preferred embodiment, the filter material is a highefficiency particulate air (HEPA) filter material, to capture 0.3 micronsized matter at 99.7% efficiency or ultra low penetration air (ULPA)filters to capture 0.1 micron sized matter at 99.99% efficiency andinclude a charcoal filter to remove toxic gases and noxious odors.

Each sheet of enclosure 12 is formed with an operating aperture 16formed therein. Operating aperture 16 extends through enclosure 12 toprovide access for the electrosurgical instrument to the skin upon whichthe enclosure 12 is placed as discussed in greater detail below. In apreferred embodiment, operating aperture 16 is sufficiently sized toallow for the performance and observation of delicate surgical work,while providing a sufficient space to allow for an incision toaccomplish such work. In a preferred embodiment, operating aperture 16is at least about three inches by three inches, or nine square inches.

Reference is now also made to FIG. 2, and FIGS. 7-9. As seen, a conduit122 is disposed within enclosure 12 between a top sheet 18 and a bottomsheet 20. In a preferred exemplary but non-limiting embodiment, conduit122 (FIGS. 7-9) is airtight and shaped to flatten and taper along thebody 122 a from one opening 122 c towards the operating aperture 16 andterminating with a mouth (opening) 122 b that widens at the apertureitself and is in fluid communication with operating aperture 16. Conduit122 may be formed as a molded plastic or resin piece.

The air tight conduit 122 is molded to fit at a proximal end 122 c inair tight fashion with either one of the sources of positive or negativepressure (i.e., air amplifier 24 or a vacuum hose) and on its distal endis shaped to a widened mouth 122 b such that the negative pressure inthe operating aperture drags the smoke plume generated through the mouth122 b of the conduit 122. The mouth 122 b has a surface area which iswidened to cover approximately one fourth to one half the circumferenceof the operating aperture 16. Additionally, the air tight conduit 122 isshaped so that it forms a circle at its proximal end 122 c that itattaches to one of either source of positive or negative pressure (i.e.air amplifier 24 or vacuum hose) and tapers and flattens at its distalend 122 b enabling the surgical drape 12 and the conduit 122 to lie flaton the patient's body and not disrupt the surgical field nor disrupt theoperating aperture 16.

In one embodiment, a positive pressure source is used to create anegative pressure at the operating aperture. An air amplifier 24 isaffixed to the opposed end 122 c of conduit 122 and is in fluidcommunication with conduit 122. Air amplifier 24 has an exhaust 26 whichin one embodiment exhausts air within enclosure 12. Because enclosure 12is made of a filter material, noxious fumes and harmful airborneparticles and disease within the plume are drawn from operating aperture16 and trapped within enclosure 12.

As known in the art, air amplifier 24 (FIG. 1) requires an air pressuresource. Accordingly a positive pressure such as an air compressor 30(FIG. 1) is coupled, optionally through an air regulator 32 (FIG. 1), tobe in fluid communication with air amplifier 24. In operation, aircompressor 30 forces air into air amplifier 24 which causes a negativeair pressure to be formed within conduit 122 and for air to exhaust fromconduit 122 through exhaust 26 of air amplifier 24. Because airamplifier 24 is in fluid communication through conduit 122 withoperating aperture 16, a negative air pressure is experienced within airoperating aperture 16 removing any smoke plume caused by an operationwithin operating aperture 16 through the mouth opening 122 b. Theexhausted air fills enclosure 12 and either passes through enclosure 12as filtered air or remains trapped within enclosure 12. At the end ofthe operation, air compressor 30 is disconnected from air amplifier 26and enclosure 12 is thrown away as a hazardous waste material inaccordance with protocols known in the art.

The characteristics of air amplifier 24 are chosen to create a vacuumwithin operating area 16 of between about −6.4 in H2O and −22 in H2O(inches of water column) dead end suction. This vacuum requirescompressed air ranging from about 10 psi to 40 psi (pounds per squareinch) and air consumption of about 6.8 SCFM to 14.9 SCFM (standard cubicfeet per minute). It has been found that a 1% inch amplifier may createenough vacuum though sizes may vary.

It should also be noted, that in a simple embodiment of the invention,rather than separated ply sheets, a single pad may be disposed overconduit 122 to create an enclosing tent over the surgical site envelopedby operating area 16. However, in this embodiment adhesive may berequired to affix the enclosure to the skin of the patient. Furthermore,in a preferred embodiment, air amplifier 24 may be affixed withinenclosure 12 utilizing an adhesive, a hanging structure formed with asheet of filter material, a velcro strap or the like. Additionally, thatportion of conduit 122 disposed within enclosure 12 may also be affixedin place to a sheet of the enclosure material utilizing velcro, a glue,or other adhesive as known in the art.

In another preferred embodiment, the trigger for turning on and turningoff the plume drape evacuator system may be linked to the trigger forturning on and turning off the electrocautery or laser device. In otherwords, the switch or pedal that controls the electrocautery device mayalso control air compressor 30. A sensor such as a touchless infraredsensor by way of non-limiting example, may be mounted at either thecompressor source or the vacuum source to sense the presence of the useof the electrocautery device or laser and to act as a switch so in thisway, the system may be operated in a touchless fashion to start and stopoperation coincident with the creation of the smoke plume.

It should be well understood, that compressor 30 provides a positivepressure in the preferred embodiment to activate air amplifier 24 whichin turn creates the vacuum at operating aperture 16. An air compressorcombined with the use of an air amplifier provides more powerefficiency, less noise and is more portable than utilizing a directvacuum. The addition of the air amplifier within the filter drapeenclosure enables a small volume of compressed air to produce a lowpressure vacuum effect that is three times the rate of the supplied air.The insertion of the air amplifier in-line within the filter drapeprovides an air driven, non electric, light with tool, that is quiet,safe, maintenance free and has no moving parts; reducing air consumptionby 70 percent and increasing energy efficiency. However, it is wellwithin the scope of the invention to directly couple a vacuum to conduit122 to create a vacuum within operating aperture 16.

Reference is now particularly made to FIGS. 3-5 in which a drape plumeevacuator, generally indicated as 110, constructed in accordance withanother embodiment of the invention is provided. For ease ofdescription, like numerals are used to indicate like structure.

In this embodiment, system 110 includes an upper filter layer 18 and ablocking barrier 130 separating upper sheet 18 from lower sheet 20.Blocking barrier 130 prevents diffusion of the smoke plume, i.e., trapsit in place. Opening 22 b of conduit 22 is disposed in barrier 130 sothat air flows in the direction of arrow A from operating aperture 16into conduit 22. Barrier 130 contains the plume in the vicinity ofopening 22 b to force more of the plume into conduit 22, away fromoperating aperture 16 preventing escape.

Another barrier (not shown) at an opposed position about operatingaperture 16 may be provided to further contain the smoke plume as it isexhausted through opening 22 b.

Reference is now made to FIG. 6 wherein a system 210, constructed inaccordance with yet another embodiment of the invention. For ease ofdescription, like numerals are utilized to indicate like structure.System 210 includes filter sheet 18 separated from bottom filter sheet(not shown) by a filter skirt 228 creating the equivalent of a filterpouch. A barrier 230 is formed about operating aperture 16 toencapsulate operating aperture 16 separating operating aperture from theremote of enclosure 12. Barrier 230 is formed of a filter material suchas HEPA filter. The filter material may even cover opening 229 whichcommunicates with an exhaust amplifier 224 coupled to an air compressor(not shown) exterior to system 210. In this way, the air is filtered asit passes to amplifier 224 which exhausts the air from exhaust 226 towithin the enclosure formed by top sheet 18, bottom sheet 20, side skirt228 and barrier 230. When done, the entire pouch of system 210 may bedisposed. Barrier 230, and barrier 130 may be formed of a sheet of morerigid material; rigid shall mean sufficient rigidity to prevent sheet 18from collapsing upon sheet 20 during operation.

By providing a surgical drape with an enclosure formed of filteringmaterial about an operating aperture, and placing the operating aperturein fluid communication with a negative pressure source, a system forevacuating the plume of smoke from the use of electrocautery or laserequipment is provided which may be operated by a single person; thesurgeon. There is no longer a need to have another person to hold theend of the surgical plume evacuator. Additionally, surgeon and surgicalassistants do not need to work around the surgical drape as isnecessitated with prior art plume evacuators and thus preventingincidental contamination of the surgical field. There is no longer aneed to have extra equipment obscuring the surgical drape aperture andfield since the drape itself will provide the function of surgical plumeevacuation. Furthermore, by utilizing an air compressor as the pressuresource, more power utilizing less electricity, with lower noise, noelectricity, and no moving parts, and in the form of a portable devicebecomes available. This is less annoying for the surgeon and provides amore pleasant experience for the patient. Furthermore, by use of thefiltered enclosure, the evacuator may make use of either a positivepressure source or a negative pressure source.

While this invention has been particularly shown and described toreference the preferred embodiments thereof, it would be understood bythose skilled in the art that various changes in form and detail may bemade therein without departing from the scope of the inventionencompassed by the impended claims.

What is claimed as new and desired to be protected by Letters Patent ofthe United States is:
 1. A surgical drape plume evacuator comprising: afilter enclosure comprising two spaced sheets of porous material joinedtogether at the edges of each of the sheets of porous material; anoperating aperture disposed in the filter enclosure and defining an areawithin the filter enclosure, serving as a barrier to keep a surgicalfield sterile and providing access to a surgical site thereto; a devicefor providing a negative air pressure to a device that creates thenegative air pressure within a conduit that is completely disposedwithin an interior of the filter enclosure, wherein the conduit isopened at both ends; and a fluid opening in the operating aperture incommunication with one open end of the conduit, wherein the conduitconnects the operating aperture to the interior of the filter enclosure,wherein the negative pressure created within the conduit by operation ofthe pressure source and device causes a smoke plume generated duringsurgery at the surgical site to drag through the conduit and into theinterior of the filter enclosure, wherein the smoke plume that isgenerated during surgery at the surgical site and is dragged through theconduit into the interior of the filter enclosure is completelyentrapped within the filter enclosure, wherein none of the smoke plumethat is entrapped within the filter enclosure is thereafter releasedfrom the interior of the filter enclosure.
 2. The surgical drape plumeevacuator of claim 1, wherein the device that creates the negative airpressure within the conduit comprises a vacuum.
 3. The surgical drapeplume evacuator of claim 2, wherein the vacuum is coupled to the conduitvia a vacuum hose.
 4. The surgical drape plume evacuator of claim 2,wherein the conduit is substantially air tight.
 5. The surgical drapeplume evacuator of claim 2, wherein the filter material comprises a highefficiency particulate air (HEPA) filter material.
 6. The surgical drapeplume evacuator of claim 2, wherein the HEPA filter material captures0.3 micron sized matter or larger at least at 99.7% efficiency.
 7. Thesurgical drape plume evacuator of claim 2, wherein the filter enclosurefurther comprises a charcoal filter.
 8. The surgical drape plumeevacuator of claim 2, wherein the filter material captures 0.1 micronsized matter or larger at least at 99.99% efficiency.
 9. The surgicaldrape plume evacuator of claim 8, wherein the filter enclosure furthercomprises a charcoal filter.
 10. The surgical drape plume evacuator ofclaim 1, further comprising means to turn the pressure source on and offthat is linked to a trigger for turning an electrocautery device or alaser on and off.
 11. A method for removing a smoke plume within asurgical drape using the surgical drape plume evacuator of claim
 2. 12.The method for removing a smoke plume within a surgical drape of claim11, wherein the smoke plume generated during surgery passes through thefilter enclosure.
 13. The method for removing a smoke plume within asurgical drape of claim 11, wherein the operation of the surgical drapeplume evacuator is coincident with the creation of the smoke plume. 14.The method for removing a smoke plume within a surgical drape of claim13, wherein the filter enclosure is discarded following surgery.